Lateral Epicondylitis Clinical Trial
Official title:
The Feasibility of Heavy-slow Resistance Training, Radial Extracorporeal Shockwave Therapy (rESWT) and Information and Advice. The NOrwegian Tennis Elbow (NOTE) Study
Verified date | March 2024 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Trial Design: The Norwegian Tennis Elbow (NOTE) study is a single-centre; three-armed, feasibility randomised controlled trial. Aim: The primary aim of this study is to pilot the methods proposed to conduct a definite RCT study. Objectives: - Measure the process of recruitment. - Measure intervention adherence and acceptability. - Measure outcome measure retention rate and completeness. The Patient-Rated Tennis Elbow Evaluation (PRTEE) will be used as the primary outcome measure. Intervention: Patients will be randomised to either: 1) Heavy slow resistance training (HSR), 2) Radial extracorporeal shock wave therapy (rESWT) or 3) Information and advice. Follow-up will be after 3 and 6 months.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 20, 2023 |
Est. primary completion date | September 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Ability to fill in the questionnaires (understand oral and written Norwegian) - Clinically diagnosed tennis elbow provoked by at least two of: Pain on pressure of the common extensor origin, Pain during power grip, Resisted wrist extension (Tomsen test), Resisted third finger extension (Maudsley´s test), Stretching of the extensors (Mill´s test) Exclusion Criteria: - Patients With significant Language issues (does not understand oral or written Norwegian - Contraindications to ESWT (pregnancy, coagulation disturbance, connective tissues disease, epilepsy, use og pacemaker) - Suspicion of other serious illness |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060. — View Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239. — View Citation
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. — View Citation
Macdermid J. Update: The Patient-rated Forearm Evaluation Questionnaire is now the Patient-rated Tennis Elbow Evaluation. J Hand Ther. 2005 Oct-Dec;18(4):407-10. doi: 10.1197/j.jht.2005.07.002. No abstract available. — View Citation
Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19. — View Citation
Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The process of recruitment | Criteria for success is that >75 percent of patients should be eligible for randomization, >90% should be willing to be randomized, recruitment rate should be 3.75 participants per month. | 2 year | |
Primary | Intervention adherence (appointments) | Criteria for success is that 90 percent meets to appointments (Either physically or tele) | 3 months | |
Primary | Intervention adherence (training sessions) | In the HSR group = 30 training sessions should be completed within 12 weeks, | 3 months | |
Primary | Intervention acceptability and understandability | = 10/20 within each group should rate the treatment =+3 "acceptable" and = 10/20 within each intervention group should rate the treatment =+3 "understandable" | 3 months | |
Primary | Retention and completeness of patient-reported outcome measures | The retention of completed patient-reported outcome measures (i.e. PRTEE, Quick DASH, EQ-5D-5L should be >75 percent. | 6 months | |
Secondary | The Patient-Rated Tennis Elbow Evaluation (PRTEE) | The Patient-Rated Tennis Elbow Evaluation (PRTEE), formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis.The questionnaire is scored from 0 - 100 and a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. Scores from The PRTEE questionaire will also be used calculate sample size in a future RCT. | 6 months | |
Secondary | Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH) | The Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH) questionnaire is an 11-item shortened version of the thirty-item DASH outcome measure. It measures physical function and symptoms related to upper-limb musculoskeletal disorders. The questionnaire is scored from 0 - 100 and a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. | 6 months | |
Secondary | The 5-level EQ-5D (EQ-5D-5L) | The 5-level EQ-5D (EQ-5D-5L) descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: Level 1: no problems, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1 digit number that expresses the level selected for that dimension, The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A total of 3125 possible health states is defined in this way. For example state "12345" indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. | 6 months | |
Secondary | The 5-level EQ-5D (EQ-5D-5L) VAS (EQ VAS) | The 5-level EQ-5D VAS (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS is scored from 0 - 100 and a lower score indicate poorer health, higher scores indicate a better health. The EQ VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 6 months | |
Secondary | Pain free grip strength | Patients will hold a hand grip dynamometer (Jamar) in a standing position with a fully extended elbow in a neutral pronation/supination. The patient will be instructed to squeeze slowly and stop squeezing at the onset of pain; the values in kg will then be registered. The pain free grip strength is measured three times at the asymptomatic side, with a 20-second rest interval between each measurement and then the procedure is repeated at the symptomatic side. After tested in fully extended position the same procedure will be followed with a 90 degrees elbow flexion, and in a neutral pronation/supination. | 3 months | |
Secondary | Maximum grip strength | Patients will hold a hand grip dynamometer (Jamar) in a standing position with a fully extended elbow in a neutral pronation/supination. The patient will be instructed to squeeze with their maximum effort; the values in kg will then be registered. The maximum grip strength is measured three times at the asymptomatic side, with a 20-second rest interval between each measurement and then the procedure is repeated at the symptomatic side. After tested in fully extended position the same procedure will be followed with a 90 degrees elbow flexion, and in a neutral pronation/supination. | 3 months | |
Secondary | Maximum grip strength pain | Immediately after each of the 12 squeezes of maximum grip strength the physiotherapist will ask the patient to rate their pain on a 10 - point NRS scale where 0 indicate no pain and 10 the worst imaginable pain. | 3 months | |
Secondary | Global improvement | The Global improvement will measure the patients change from baseline. With a scale ranging from -5 to +5, where -5 is maximum worsening 0 is unchanged, and +5 is completely recovered. Patients will also answer whether they experience the change as meaningful. | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02308514 -
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
|
N/A | |
Completed |
NCT02596659 -
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
|
N/A | |
Completed |
NCT00674622 -
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
|
Phase 2/Phase 3 | |
Completed |
NCT06206109 -
The Effect of Tendon Tears on Lateral Epicondylitis
|
||
Completed |
NCT06301152 -
Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy
|
N/A | |
Not yet recruiting |
NCT04382144 -
Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
|
Phase 4 | |
Recruiting |
NCT03863847 -
A Neurofeedback Treatment for Chronic Musculoskeletal Pain
|
N/A | |
Recruiting |
NCT05648032 -
PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
|
Phase 3 | |
Completed |
NCT06300749 -
Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis
|
N/A | |
Completed |
NCT00794976 -
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
|
Phase 2 | |
Completed |
NCT00888225 -
Tennis Elbow Trial
|
N/A | |
Completed |
NCT06087081 -
Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis
|
N/A | |
Completed |
NCT05602571 -
The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis
|
N/A | |
Completed |
NCT05566418 -
Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis
|
N/A | |
Not yet recruiting |
NCT03279796 -
Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells
|
Phase 2 | |
Completed |
NCT04687943 -
Comparison of PELOID Therapy and Kinesio Tape Effectiveness in Patients With Lateral Epicondylitis
|
||
Recruiting |
NCT05947968 -
Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
|
N/A | |
Active, not recruiting |
NCT06438328 -
Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients
|
N/A | |
Completed |
NCT06317545 -
Effects of Nerchal Exercises on Lateral Epicondylitis.
|
N/A | |
Completed |
NCT05070559 -
Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis
|
N/A |